Type of study in modified release formu­lation EMEA [Regulatives / Guidelines]

posted by fno Homepage – Belgium, 2014-03-13 12:16 (4070 d 04:58 ago) – Posting: # 12615
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❝ "A multiple dose study is needed unless a single dose study has been performed with the highest strength which has demonstrated that the mean AUC(0-τ) after the first dose covers more than 90% of mean AUC(0-∞) for both test and reference, and consequently a low extent of accumulation is expected".


This does not seem so cryptic anyway...

Let's assume a once daily dosing is the standard regimen for the originator (reference) product.
You have to perform a BE single dose study with both test and reference formulations at the highest registered strength and compute AUC0-24h and AUC0-inf. If this study demonstrate that AUC0-24h > 0.9 × AUC0-inf for both test and reference, it is not necessary to perform a MD BE study.

Hope this helps.
—
Kind regards,
Fabrice

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